Life Sciences Insight

Abbott scores FDA clearance for its latest EnSite heart mapping platform

Abbott has scored clearance from the FDA for its latest 3D cardiac mapping platform, designed to help physicians target abnormal heart rhythms. 

The EnSite X EP system threads a catheter into the heart to chart out the regions of the cardiac muscle where unsteady electric pulses can cause irregular heartbeats and then guides surgeons in treating those areas with ablation procedures.

The device incorporates Abbott’s omnipolar technology, which allows the probe to accurately record 360 degrees of electrical activity in real time, regardless of how the catheter is oriented within the heart’s chambers.

According to the company, the system can map 1 million points in the heart while allowing the user to employ both unipolar and bipolar measurement principles, enabling both wider viewing of the heart as well as pinpoint measuring for specific areas of concern.

If left untreated, these erratic heartbeats—which affect millions of people in the U.S., with one of the most common arrhythmias being atrial fibrillation—can develop into serious cases of heart failure or lead to higher risks of stroke. 

Abbott’s new clearance comes just days after Medtronic announced a $925 million tuck-in deal at the annual J.P. Morgan Healthcare Conference to acquire Affera and its catalog of heart-mapping catheters.

That buyout, slated to close before this November, will add Affera’s products currently under development, including the Prism-1 cardiac mapping and navigation platform, the Arc-10 Linear coronary sinus catheter and the Sphere-9 catheter, which offers both focal ablation therapy and high-definition mapping abilities.